Z-1102-06

Boston Scientific Wiseguide Guide Catheter 7F, .076 '', Femoral Approach, Manufactured for Boston Scientific...

Name: Z-1102-06 Boston Scientific Wiseguide Guide Catheter 7F, .076 '', Femoral Approach, Manufactured for Boston Scientific...
Creator: Boston Scientific
Published: 2006-05-22
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-05-22 / Terminated

FDA source

Boston Scientific began a recall of Boston Scientific Wiseguide Guide Catheter 7F, .076 '', Femoral Approach, Manufactured for Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN... on 2006-05-22. The reason FDA records is "Gaps were identified between polymer segments on the 7F Wiseguide Guide Catheter in which the PTFE was not properly laminated to the braid of the catheter. This delamination of the PTFE from the braid could compromise...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1102-06
Status: Terminated
Initiated: 2006-05-22
Posted: 2006-06-10
Terminated: 2006-12-30
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Wiseguide Guide Catheter 7F, .076 '', Femoral Approach, Manufactured for Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311. Nonpyrogenic.
Product code: DQY Catheter, Percutaneous
Reason for recall: Gaps were identified between polymer segments on the 7F Wiseguide Guide Catheter in which the PTFE was not properly laminated to the braid of the catheter. This delamination of the PTFE from the braid could compromise the device delivery.
FDA root cause: Other
Action: Affected customers were mailed an Urgent Medical Device Recall or Correction - Immediate Action Required letter, dated 05/22/2006. The letter describes the issue, states to immediately discontinue use of and segregate recalled product, provides instructions to ship product back to Boston Scientific and asks for the Reply Verification Tracking Form to be faxed to Boston Scientific in acknowledgement.
Quantity in commerce: 75
Distribution: Nationwide- States of AZ, CA, CO, FL, HI, KS, MI, NV, OK, TX, VA.
Product codes and lots: Catalog number 19500-448, Lot # 655713; Catalog number 19500-498, Lot # 655721; Catalog number 19500-08, Lot # 657310; Catalog number 19500-09, Lot # 657311; Catalog number 19500-132, Lot # 655680; Catalog number 19500-27, Lot # 655695;

Product code DQY

K974684Class IIScimed 7 French Wiseguide Guide CatheterScimed Life Systems, Inc. / cleared 1998-02-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)